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Assaig Clínic Multicèntric de Fase III×Assaig Clínic Aleatoritzat Adaptatiu×
CampEpidemiologiaEpidemiologia
FamíliaProcess / pipelineProcess / pipeline
Any d'origen1940s–1990s (formalized through ICH harmonization ~1990s)Late 1990s–2000s (widespread adoption post-2010)
Autor originalCodified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA)Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
TipusConfirmatory interventional study designExperimental clinical trial design
Font seminalFriedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
ÀliesPhase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trialadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
Relacionats66
ResumA multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites.An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.
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ScholarGateCompara mètodes: Multicenter Phase III Clinical Trial · Adaptive Randomized Clinical Trial. Recuperat el 2026-06-19 de https://scholargate.app/ca/compare